FDA Limitations Could Endanger Growth Of mHealth

Posted on December 28, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

mHealth technology has virtually unlimited potential. But until the FDA begins putting its stamp of approval on mHealth tools, many providers won’t take them seriously. And that could be a big problem for mHealth’s future.

Unfortunately, early signs seem to suggest that the FDA is in over its head when it comes to regulating mHealth. According to speakers at a recent FDA Law Institute conference, it could be years before the agency even has a solid idea of how to proceed, Bloomberg reports.

Jeffrey Shapiro, a member of the Washington, D.C. law firm of Hyman Phelps & McNamara P.C., told the conference the FDA just isn’t equipped to handle the flood of new mHealth approaches. “Experience has shown that the FDA’s almost 40-year-old regulatory framework is a bad fit for much of today’s health IT with its networked ecosystems, rapid iterative improvement, deep collaboration between providers and end-users and focus on clinical decision support rather than direct diagnosis or treatment,” he told the audience.

The FDA dismisses the notion that it’s not prepared to regulate mHealth technologies. Bakul Patel, the agency’s associate director for digital health, told Reuters that the agency is planning to fill three new senior health scientist positions focused on digital health soon. That’s an encouraging step, though given that there are more than 165,000 health apps on the market, probably an inadequate one.

Sure, few of those app developers will apply for FDA approval. And the agency only plans to demand approval for technologies that are designed to be used as an accessory to a regulated medical devices, or transform a mobile platform into a regulated medical device. mHealth devices it has already approved include Airstrip Remote Patient Monitoring, the AliveCor Heart Monitor for iPhone and McKesson Cardiology’s ECG Mobile.

On the other hand, if Shapiro is right, the FDA could become a bottleneck which could severely stunt the growth of the U.S. mHealth industry. If nothing else, mHealth developers who seek FDA approval could be faced with a particularly prolonged approval process. While vendors wait for approval, they can keep innovating, but if their proposed blockbuster product is in limbo, it won’t be easy for them to stay solvent.

Not only that, if the FDA doesn’t have the institutional experience to reasonably evaluate such technologies, the calls it makes as to what is safe and efficacious may be off base. After all, apps and remote monitoring tools don’t bear much resemblance to traditional medical devices.

In theory, upstart mHealth companies which don’t have the resources to go through the FDA approval process can just proceed with their rollout. After all, the agency’s guidelines for requiring its approval are reasonably narrow.

But in reality, it seems unlikely that providers will adopt mHealth devices and apps wholesale until they get the FDA stamp of approval.  Whether they geniunely consider non-approved devices to be too lightweight for use, or fear being sued for using questionable technology, providers seem unlikely to integrate mHealth technology into their daily practice without the agency’s green light.

Given these concerns, we’d best hope that the FDA doesn’t begin requiring its approval for EMRs. Or at the very least, we should be glad that it didn’t jump in early. Who knows where EMR infrastructure would be if vendors had had to play patty-cake with the FDA from day one?